REACH

The abbreviation "REACH" stands for "Registration, Evaluation and Authorisation of Chemicals".
REACH affects manufacturers, importers, and also users of chemicals. In the old EU legislation for the authorisation of chemical substances there were various rules for "old substances" (substances marketed before September 1981) and "new substances".

 

Further general information at:

» What is REACH

»http://echa.europa.eu/reach_en.asp


REACH

As a result of the chemical legislation in the EU a greater need exists especially for small and mid-sized companies which work with chemicals (production, processing, trade, etc.) to have suitable information available about the utilised substances for the purpose of authorisation on the one hand and for their customers on the other hand and to compile this information in a suitable manner. Such data are frequently not available in the necessary scope. An experimental formulation of the required data is expensive and time consuming. Particularly in the case of high tonnage, the data requirements under REACH are comprehensive. REACH however also enables a considerable lessening of the test expenditure due to:

  • Consistent usage of pre-existing data (e.g. extensive literature research or usage of (quantitative) structural property/activity relationships, Q(SAR).
  • Grouping (Category approach): Several structurally similar chemicals can be combined so that only one dossier must be submitted. The basis for this is formed by literature and data bank research as well as (Q)SAR.
  • Bridging: If data from a structurally similar chemicals exist, these data can be used for a new material (literature and data bank research).
  • Waiving: If it is shown that no kind of exposure to a chemical can be expected, then the corresponding tests can be dispensed with (literature and data bank research, optimisation of chemicals and pharmaceuticals, benign by design).

EDC provides support in these areas through competent consultation or complete processing.

 

REACH took effect on June 1, 2007. REACH should guarantee a high level of protection for health and environment. It should also assure and improve the free commerce of chemicals in the domestic market, competitive capacity and innovation. The precautionary principle lies at the centre of REACH. REACH is based on the principle that manufacturers, importers, and downstream users assure that they will only produce, market, and use chemicals which are not harmful to human health and the environment. Insofar as a chemical is produced or imported in a quantity of > 1 ton annually, this chemical must be registered by REACH.
Depending on the imported or produced chemical quantity, for this purpose various data about the health and environmental risks must be submitted. For chemicals as such or preparations it is necessary for a manufacturer or importer who produces or imports a chemical as such or in one or more preparations in a quantity of at least 1 ton annually to submit a registration dossier. For chemicals in manufactured products it is required that the manufacturer or importer submits a registration dossier for the chemicals contained in this product, in case:

  • The chemical in this product is contained in a total quantity greater than 1 ton per year
  • The chemical is intentionally discharged under normal or reasonably predictable usage conditions.

A registration dossier consists of a technical dossier as well as a material safety report for a tonnage > 10 tons annually.

  • 2008-06-01 - 2008-12-01: Preregistration
    List of the preregistered materials:
    http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx

  • 2008-06-01 - 2010-12-01: Materials > 1000 t/a
                                                    CMR chemicals (Categ. 1/2) < 1 t/a;
                                                    Chemicals  with R50/53 > 100 t/a

  • 2008-06-01 - 2013-06-01: Chemicals > 100 t/a to 1000 t/a

  • 2008-06-01 - 2018-06-01: Chemicals > 1 t/a to 1000 t/a  

Further information at:

European Chemical Agency: http://echa.europa.eu/reach_en.asp

 
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© EDC Chemical Consulting | Tue, May 21st, 2019